To test the efficacy of FACE-TC on key outcomes, the investigators propose using an intent-to-treat, longitudinal, prospective, multi-site, randomized controlled trial (RCT) design. Adolescents with cancer, aged 14 up to 20 years, and their families (N=130 dyads; N=260 participants) will be recruited and randomized to FACE-TC or Treatment as Usual (TAU) control. Participants will complete standardized questionnaires at baseline and 3, 6, 12, and 18 months post-intervention. Our goal is to assess the extent to which FACE-TC helps adolescents and young adults with cancer and their families: (1) reach and maintain better congruence in treatment preferences over time; (2) improve their quality of life; and (3) document goals of care and advance directives earlier in the course of their potentially life limiting illness.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
FAmily CEntered Advance Care Planning for Teens with Cancer
Behavioral
—
UNRESOLVED
Design
Arms and outcomes
Arms (2)
type
EXPERIMENTAL
label
FACE-TC Intervention
description
Adolescent/family dyads randomized to the experimental condition receive Family Centered Advance Care Planning for Teens with Cancer (FACE-TC) intervention - 3 sessions scheduled one week apart of approximately 60 minutes duration each. Session 1 - Lyon Advance Care Planning Survey-Adolescent \& Surrogate versions. Session 2 - Respecting Choices Interview facilitated by trained/certified facilitator with adolescent and family. Focuses on patient's understanding of their illness, possible complications, goals of care and treatment preferences in 3 bad outcome situations; and the Session 3 - Five Wishes an advance directive.
interventionNames
Behavioral: FAmily CEntered Advance Care Planning for Teens with Cancer
type
NO_INTERVENTION
label
Treatment As Usual (TAU)
description
Adolescent/family dyads randomized to the treatment as usual (TAU) condition receive written information on advance care planning, but no active intervention.
Primary outcomes (1)
Eligibility
Eligibility (as posted)
Sex
All
Minimum age
14 Years
Maximum age
99 Years
Show eligibility criteria text
AYA Inclusion Criteria:
* Ever diagnosed with cancer;
* Knows his or her cancer status;
* Ages of 14 up to 20 years;
* Ability to speak English;
* Consent from the legal guardian for adolescents aged 14-17;
* Consent from a surrogate for adolescents aged 18-20;
* Assent from adolescent aged 14-17;
* Consent from adolescent aged 18-20;
Inclusion Criteria for Legal Guardians of Adolescents Age 14-17:
* Legal guardian of assenting adolescent participant;
* Knows cancer status of adolescent;
* Adolescent willingness to discuss problems related to cancer with them;
* Age 18 or older;
* Ability to speak English;
* Consent to participate; Consent for his/her adolescent to participate;
Inclusion Criteria for Surrogates of AYAs Age 18-20:
* Selected by adolescent aged 18 to 20;
* Knows cancer status of adolescent;
* Age 18 or older;
* Ability to speak English;
* Willingness to discuss problems related to cancer and EOL;
* Consent to participate;
Exclusion Criteria - for AYA or surrogate decision-maker:
Developmental delay; foster care; active homicidality or suicidality, depression in the severe range
References
Publications (35)
BACKGROUNDLyon ME, Jacobs S, Briggs L, Cheng YI, Wang J. A longitudinal, randomized, controlled trial of advance care planning for teens with cancer: anxiety, depression, quality of life, advance directives, spirituality. J Adolesc Health. 2014 Jun;54(6):710-7. doi: 10.1016/j.jadohealth.2013.10.206. Epub 2014 Jan 7. PMID 24411819
BACKGROUNDLyon ME, Jacobs S, Briggs L, Cheng YI, Wang J. Family-centered advance care planning for teens with cancer. JAMA Pediatr. 2013 May;167(5):460-7. doi: 10.1001/jamapediatrics.2013.943. PMID 23479062
BACKGROUNDLyon ME, Garvie PA, Briggs L, He J, McCarter R, D'Angelo LJ. Development, feasibility, and acceptability of the Family/Adolescent-Centered (FACE) Advance Care Planning intervention for adolescents with HIV. J Palliat Med. 2009 Apr;12(4):363-72. doi: 10.1089/jpm.2008.0261. PMID 19327074
BACKGROUNDLyon ME, Garvie PA, Briggs L, He J, Malow R, D'Angelo LJ, McCarter R. Is it safe? Talking to teens with HIV/AIDS about death and dying: a 3-month evaluation of Family Centered Advance Care (FACE) planning - anxiety, depression, quality of life. HIV AIDS (Auckl). 2010;2:27-37. doi: 10.2147/hiv.s7507. Epub 2010 Feb 18. PMID 22096382
BACKGROUNDLyon ME, Garvie PA, McCarter R, Briggs L, He J, D'Angelo LJ. Who will speak for me? Improving end-of-life decision-making for adolescents with HIV and their families. Pediatrics. 2009 Feb;123(2):e199-206. doi: 10.1542/peds.2008-2379. PMID 19171571
BACKGROUNDJacobs S, Perez J, Cheng YI, Sill A, Wang J, Lyon ME. Adolescent end of life preferences and congruence with their parents' preferences: results of a survey of adolescents with cancer. Pediatr Blood Cancer. 2015 Apr;62(4):710-4. doi: 10.1002/pbc.25358. Epub 2014 Dec 24. PMID 25545105
BACKGROUNDWilkins ML, Dallas RH, Fanone KE, Lyon ME. Pediatric palliative care for youth with HIV/AIDS: systematic review of the literature. HIV AIDS (Auckl). 2013 Jul 29;5:165-79. doi: 10.2147/HIV.S44275. Print 2013.
measure
Statement of Treatment Preferences (SOTP) a Tool to Measure Goals of Care.
timeFrame
Agreement on SOTP was assessed 2 weeks post-baseline for controls or immediately following Session 2 for FACE-TC intervention dyads, and at 3, 6, 12 and 18 months.
description
Statement of Treatment Preferences documented adolescents' goals of care and families' understanding. Situations were: (1) prolonged hospital stay with ongoing medical intervention and low chance of survival; (2) treatments extend life by no more than 2-3 months with side-effects; (3) physical impairment; and (4) mental impairment. Choices for the four situations were "to continue all treatments …", "to stop all efforts to keep me alive…", or "do not know." Responses for data analysis were recoded into two categories: congruent (family accurately reported what the patient reported as their treatment preference) versus "stop all treatments." Dyadic responses, "do not know" were treated as not congruent and removed from analysis. Percentage dyadic agreement or disagreement was calculated for each situation. Minimum agreement is 0%. Maximum agreement is 100%. Higher percentage dyadic agreement is better outcome.
Secondary outcomes (4)
measure
Patient-Reported Outcomes Measurement Information System (PROMIS Short Forms 8a - Pediatrics v. 2.0) is a Set of Person-centered Measures That Evaluates and Monitors Physical, Mental, and Social Health in Children and Adolescents.
timeFrame
Change from baseline in quality of life (defined as symptoms of anxiety, depression, fatigue and pain interference) at 3, 6, and 12 months post baseline compared to controls
description
Assessed adolescent Emotional distress-Anxiety; Emotional Distress-Depressive Symptoms; Fatigue; and Pain Interference using these PROMIS subscales. Each subscale has 8 items each. Minimum value is 8. Maximum value is 40. Higher scores mean worse outcomes for anxiety, depressive symptoms, fatigue, and pain interference.
measure
Functional Assessment of Chronic Illness Therapy (FACIT)-Spirituality-12 Version 4 Expanded (FACIT-Sp-EX)
timeFrame
Controlling for baseline, change in of meaning and peace subscale and faith subscale at 3, 6, 12 months post intervention for intervention adolescents compared to control adolescents. Total scores provided for interested investigators were not outcome.
description
Assessed construct of spiritual well-being. Two subscales Meaning/Peace (7 items) and Faith (5 items) and Total score (12 items) were calculated. on a 5-point Likert scale from 0=not at all to 5=very much. Some items are reverse scored. See www.facit.org Meaning/Peace subscale score range from minimum value of 0 to maximum value of 32. Higher scores indicate better meaning/peace.
Faith subscale score range from 0 minimum value to maximum value of 16. Higher scores indicate better meaning/peace.
Total score range is from 0 minimum value to maximum value of 92. Higher scores indicate better spiritual well-being.
measure
Family Appraisal of Caregiving Questionnaire for Palliative Care (FACQ-PC)
timeFrame
Baseline and 3 months post baseline administered to family surrogates only.
description
The FACQ-PC is a 25-item measure consists of four theoretically derived subscales: (i) caregiver strain, (ii) positive caregiving appraisals, (iii) caregiver distress, and (iv) family well-being. Scores are from 5 = strongly agree to 1 = strongly disagree. We did not calculate a Total score. We only used the 4 subscale scores. On the subscale scores for positive caregiving appraisals and family well-being, higher scores mean better outcomes, i.e. greater positive caregiving appraisals or family well-being. On the subscale scores for caregiver strain and caregiver distress, higher scores mean worse outcomes, i.e. greater caregiver strain or caregiver distress. The FACQ-PC subscale scores were computed by taking the mean of the items (score range 1-5). Some items were reverse scored, depending on how the item is phrased, so that higher scores = higher amount of the subscale being measured. So the minimum value for each subscale is 1 and the maximum value for each subscale is 5.
measure
Advance Directive for Adolescent Only Located in the Electronic Health Record at Study Close Out.
timeFrame
This adolescent outcome was measured at one time point only, between 18 months post-intervention or study close-out. At study close out we had 117 adolescents in the study. Attrition was due to deaths, lost to follow-up, and withdrawals.
description
The effect of the intervention on documentation in the Electronic Health Record of any advance directive for the adolescent was conducted at study close, using a standardized chart abstraction form.
BACKGROUNDGarvie PA, He J, Wang J, D'Angelo LJ, Lyon ME. An exploratory survey of end-of-life attitudes, beliefs, and experiences of adolescents with HIV/AIDS and their families. J Pain Symptom Manage. 2012 Sep;44(3):373-85.e29. doi: 10.1016/j.jpainsymman.2011.09.022. Epub 2012 Jul 7. PMID 22771129
BACKGROUNDLyon ME, McCabe MA, Patel KM, D'Angelo LJ. What do adolescents want? An exploratory study regarding end-of-life decision-making. J Adolesc Health. 2004 Dec;35(6):529.e1-6. doi: 10.1016/j.jadohealth.2004.02.009. PMID 15581537
BACKGROUNDRosenberg AR, Wolfe J, Wiener L, Lyon M, Feudtner C. Ethics, Emotions, and the Skills of Talking About Progressing Disease With Terminally Ill Adolescents: A Review. JAMA Pediatr. 2016 Dec 1;170(12):1216-1223. doi: 10.1001/jamapediatrics.2016.2142. PMID 27749945
BACKGROUNDLyon ME, D'Angelo LJ, Dallas RH, Hinds PS, Garvie PA, Wilkins ML, Garcia A, Briggs L, Flynn PM, Rana SR, Cheng YI, Wang J. A randomized clinical trial of adolescents with HIV/AIDS: pediatric advance care planning. AIDS Care. 2017 Oct;29(10):1287-1296. doi: 10.1080/09540121.2017.1308463. Epub 2017 Mar 30. PMID 28359212
BACKGROUNDWeaver MS, Anderson B, Cole A, Lyon ME. Documentation of Advance Directives and Code Status in Electronic Medical Records to Honor Goals of Care. J Palliat Care. 2020 Oct;35(4):217-220. doi: 10.1177/0825859719860129. Epub 2019 Jul 7. PMID 31280659
BACKGROUNDFeudtner C, Rosenberg AR, Boss RD, Wiener L, Lyon ME, Hinds PS, Bluebond-Langner M, Wolfe J. Challenges and Priorities for Pediatric Palliative Care Research in the U.S. and Similar Practice Settings: Report From a Pediatric Palliative Care Research Network Workshop. J Pain Symptom Manage. 2019 Nov;58(5):909-917.e3. doi: 10.1016/j.jpainsymman.2019.08.011. Epub 2019 Aug 21. PMID 31445136
BACKGROUNDWatson A, Weaver M, Jacobs S, Lyon ME. Interdisciplinary Communication: Documentation of Advance Care Planning and End-of-Life Care in Adolescents and Young Adults With Cancer. J Hosp Palliat Nurs. 2019 Jun;21(3):215-222. doi: 10.1097/NJH.0000000000000512. PMID 30829829
BACKGROUNDNeedle J, Brunnquel D, Lyon M. Mature minors, mature decisions: Advance care planning for adolescent patients with life-limiting illness. Journal of Pediatric Ethics! Advanced Care Planning and End of Life. 2018;1(3).
BACKGROUNDWeaver MS, Bell CJ, Diver JL, Jacobs S, Lyon ME, Mooney-Doyle K, Newman AR, Slutsman J, Hinds PS. Surprised by Benefit in Pediatric Palliative Care Research. Cancer Nurs. 2018 Jan/Feb;41(1):86-87. doi: 10.1097/NCC.0000000000000576. No abstract available. PMID 29206683
BACKGROUNDNeedle JS, Peden-McAlpine C, Liaschenko J, Koschmann K, Sanders N, Smith A, Schellinger SE, Lyon ME. "Can you tell me why you made that choice?": A qualitative study of the influences on treatment decisions in advance care planning among adolescents and young adults undergoing bone marrow transplant. Palliat Med. 2020 Mar;34(3):281-290. doi: 10.1177/0269216319883977. Epub 2019 Oct 29. PMID 31659933
BACKGROUNDWiener L, Zadeh BS, Battles H, Sender L, Fasciano K, Heath C, Lyon ME, Donavan KA, Naronoha Ferrazde Arruda Colli M, Pao M. Courageous Conversations: Advance Care Planning and Family Communication. Pediatric Blood & Cancer, S596, October, 2018
RESULTCurtin KB, Watson AE, Wang J, Okonkwo OC, Lyon ME. Pediatric advance care planning (pACP) for teens with cancer and their families: Design of a dyadic, longitudinal RCCT. Contemp Clin Trials. 2017 Nov;62:121-129. doi: 10.1016/j.cct.2017.08.016. Epub 2017 Aug 24. PMID 28844985
RESULTGaines ThompkinsJ, Friebert S, Baker J, Needle J, Cheng Y, Lyon M. Effect of FAmily CEntered (FACE) advance care planning (ACP) on families' appraisals of caregiving for their teens with cancer. J Pain Symptom Manage 2019;57(2):446-447. PMID: 30267845
RESULTFriebert S, Gaines (Thompkins) J, Needle J, Baker J, Cheng Y, Lyon M. What do adolescents want? Values, goals and beliefs of teens with cancer. J Pain Symptom Manage 2019;57(2):378.
RESULTGrossoehme DH, Friebert S, Baker JN, Tweddle M, Needle J, Chrastek J, Thompkins J, Wang J, Cheng YI, Lyon ME. Association of Religious and Spiritual Factors With Patient-Reported Outcomes of Anxiety, Depressive Symptoms, Fatigue, and Pain Interference Among Adolescents and Young Adults With Cancer. JAMA Netw Open. 2020 Jun 1;3(6):e206696. doi: 10.1001/jamanetworkopen.2020.6696. PMID 32543698
RESULTFriebert S, Grossoehme DH, Baker JN, Needle J, Thompkins JD, Cheng YI, Wang J, Lyon ME. Congruence Gaps Between Adolescents With Cancer and Their Families Regarding Values, Goals, and Beliefs About End-of-Life Care. JAMA Netw Open. 2020 May 1;3(5):e205424. doi: 10.1001/jamanetworkopen.2020.5424. PMID 32427325
RESULTThompkins J, Baker JN, Friebert S, Needle J, Wang J, Cheng YI, Lyon ME. Effect of FAmily CEnterd (FACE) advance care planning (ACP) on families' appraisals of caregiving for their teen with cancer. 2020 American Society of Clinical Oncology (ASCO) Annual Meeting. (ASCO Virtual Scientific Program). J Clin Oncol 38: 2020 (suppl; abstr e22533) DOI:10.1200/JCO.2020.38.15_suppl.e2253
RESULTSchreiner KL, Grossoehme DH, Baker JN, Needle J, Friebert S, Lyon ME. Being healthy and living life as if I never had cancer": The meaning of "living well" from adolescents with cancer. J Clin Oncol 38: 2020 (suppl; abstr e22532) DOI: 10.1200/JCO.2020.38.15_suppl.e22532
RESULTLivingston J, Cheng Y, Wang J, Tweddle T, Friebert S, Baker J, Thompkins J, Greenberg I, Lyon M. FP029 SIOP19-1654 Shared Spiritual Beliefs Between Adolescents with Cancer and Their Families: An Exploration of Social Determinants of Spiritual Well-Being. Supplement: Abstracts from the 51st Congress of the International Society of Paediatric Oncology (SIOP) Lyon, France, October 23-26, 2019 Pediatric Blood & Cancer. December 2019;66: IssueS4 e27989 https://doi.org/10.1002/pbc.27989
RESULTAbstracts from the 51st Congress of the International Society of Paediatric Oncology (SIOP) Lyon, France, October 23-26, 2019. Pediatr Blood Cancer. 2019 Dec;66 Suppl 4:e27989. doi: 10.1002/pbc.27989. No abstract available. PMID 31568621
RESULTLyon ME, Grossoehme DH, Baker JN, Friebert S, Cheng Y, Chrastek J, Thompkins J, Tweddle M, Wang J, Needle J. Relationship of spiritual constructs to mental health PROs in adolescents with cancer.DOI: 10.1200/JCO.2019.37.31_suppl.136 Journal of Clinical Oncology 37, no. 31_suppl (November 01, 2019) 136-136. Published online November 25, 2019
RESULTNeedle JS, Friebert S, Thompkins JD, Grossoehme DH, Baker JN, Jiang J, Wang J, Lyon ME. Effect of the Family-Centered Advance Care Planning for Teens with Cancer Intervention on Sustainability of Congruence About End-of-Life Treatment Preferences: A Randomized Clinical Trial. JAMA Netw Open. 2022 Jul 1;5(7):e2220696. doi: 10.1001/jamanetworkopen.2022.20696. PMID 35819787
RESULTBaker JN, Friebert S, Needle J, Jiang J, Wang J, Lyon ME. An Intervention in Congruence for End-of-Life Treatment Preference: A Randomized Trial. Pediatrics. 2022 May 1;149(5):e2021054796. doi: 10.1542/peds.2021-054796. PMID 35425986
RESULTThompkins JD, Needle J, Baker JN, Briggs L, Cheng YI, Wang J, Friebert S, Lyon ME. Pediatric Advance Care Planning and Families' Positive Caregiving Appraisals: An RCT. Pediatrics. 2021 Jun;147(6):e2020029330. doi: 10.1542/peds.2020-029330. Epub 2021 May 6. PMID 33958436
RESULT- Baker JN (presenter), Friebert S, Needle JS, Thompkins JD, Grossoehme D, Jiang J, Wang J, Lyon ME. Oral Presentation. The effect of Family-Centered pediatric Advance Care Planning for Teens with Cancer (FACE®-TC) on adolescents' decisional support, preparedness, and symptoms at 3- and 12- months post-intervention. 54th Congress of the International Society of Paediatric Oncologists (SIOP). September 29, 2022. Barcelona, Spain
RESULTLyon ME, Cheng YI, Needle J, Friebert S, Baker JN, Jiang J, Wang J. The intersectionality of gender and poverty on symptom suffering among adolescents with cancer. Pediatr Blood Cancer. 2021 Aug;68(8):e29144. doi: 10.1002/pbc.29144. Epub 2021 Jun 1. PMID 34061435
RESULTLivingston J, Cheng YI, Wang J, Tweddle M, Friebert S, Baker JN, Thompkins J, Lyon ME. Shared spiritual beliefs between adolescents with cancer and their families. Pediatr Blood Cancer. 2020 Dec;67(12):e28696. doi: 10.1002/pbc.28696. Epub 2020 Sep 12. PMID 32918519
RESULTFriebert S, Trujillo Rivera EA, Baker JN, Thompkins JD, Grossoehme D, Needle J, Lyon ME. Pediatric Advance Care Planning and Adolescent Preparedness and Quality of Life: An RCT. Pediatrics. 2025 Feb 1;155(2):e2024068699. doi: 10.1542/peds.2024-068699. PMID 39821687
United States
4
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Trial listing is informational. Eligibility is decided by the study team; contact information is on ClinicalTrials.gov.